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• TF2 and 68 Ga-IMP-288

Phase 1

Medullary Thyroid Carcinoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Jul 26, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01730638ImmunoTEP for Patients With Medullary Thyroid Carcinoma.PHASE1 COMPLETED 25Jan 1, 2013Dec 1, 2016Jul 26, 20223 France
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Study Endpoints
Primary Endpoints
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
one week

Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.

Secondary Endpoints
Sensibilité
6 monts after immunoTEP
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
TF2 antibody/68Ga-IMP-288EXPERIMENTALTF2 coupled with 68 Ga-IMP-288
Interventions
NameTypeDescription
• TF2 and 68 Ga-IMP-288DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histological diagnosis of CMT * Calcitonin\> 150 pg / ml * Complete treatment of the primary tumor * at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is me...

Countries:France
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